Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: September 6, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171977

Purpose

This is a multicenter, post-marketing, clinical study aimed to evaluate the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in GIST patients in terms of relapse-free survival in high-risk GIST patients receiving 400 mg of Imatinib Mesylate for one year (48 weeks), by confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors. Also, this study aims to assess the overall survival, relapse-free survival rate and overall survival rate in these patients and the safety of the study drug

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Imatinib Mesylate	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the relapse-free survival (RFS) in patients receiving postoperative adjuvant therapy

Secondary Outcome Measures:

To evaluate overall survival, relapse free
Safety

Estimated Enrollment:	60
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

underwent macroscopically curative resection;
immunohistochemically confirmed KIT (CD117)-positive tumors;
judged as being high-risk according to the criteria for risk classification

Exclusion Criteria

synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
received therapy with Imatinib Mesylate prior to study entry;
cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)

Other protocol-defined inclusion / exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171977

Locations

Japan

Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CSTI571BJP07
Study First Received:	September 13, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00171977 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

GIST
Imatinib
Postoperative Adjuvant

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Adjuvants, Immunologic
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on May 06, 2009